Cleared Traditional

OPD-STATION SOFTWARE

K050336 · Nidek, Inc. · Ophthalmic

Aug 2005

Decision

195d

Days

Class 1

Risk

About This 510(k) Submission

K050336 is an FDA 510(k) clearance for the OPD-STATION SOFTWARE, a Aberrometer, Ophthalmic (Class I — General Controls, product code NCF), submitted by Nidek, Inc. (Lake Forest, US). The FDA issued a Cleared decision on August 24, 2005, 195 days after receiving the submission on February 10, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number	K050336 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 2005
Decision Date	August 24, 2005
Days to Decision	195 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF